Набор скоро начнётся NCT07390097

Calcium Dobesilate After Radiofrequency Ablation for Varicose Veins

Фаза IV С лечением Varicose Veins Leg Great Saphenous Vein Insufficiency Chronic Venous Insufficiency

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: calcium dobesilate.
Кому может быть актуально: Состояния в реестре: Varicose Veins Leg, Great Saphenous Vein Insufficiency, Chronic Venous Insufficiency. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Perioperative Calcium Dobesilate on Postprocedural Pain, Symptom Relief, and Quality of Life After Radiofrequency Ablation for Great Saphenous Vein Insufficiency: A Randomized Controlled Trial

Обзор

This study evaluates whether calcium dobesilate, a venoactive drug, improves recovery after radiofrequency ablation (RFA) for varicose veins. Patients with great saphenous vein insufficiency undergoing RFA will be randomly assigned to receive either calcium dobesilate (500 mg twice daily) or standard care alone. The treatment starts 7 days before the procedure and continues for 30 days after. The primary outcome is postoperative pain at day 7. Secondary outcomes include pain at days 14 and 30, quality of life, ecchymosis, and return to daily activities.

Подробное описание

Radiofrequency ablation (RFA) is a minimally invasive treatment for great saphenous vein insufficiency. Although effective, patients may experience postprocedural pain, ecchymosis, and discomfort during recovery. Venoactive drugs have been shown to reduce symptoms in chronic venous disease and may improve recovery after venous procedures.

Calcium dobesilate is a venoactive agent that reduces capillary permeability, inhibits platelet aggregation, and has anti-inflammatory properties. It is approved for chronic venous insufficiency treatment in many countries including Turkey.

This prospective, randomized, open-label, controlled trial will investigate whether perioperative calcium dobesilate administration improves clinical outcomes after RFA. Approximately 100 patients will be enrolled and randomized 1:1 to either:

* Intervention group: Calcium dobesilate 500 mg twice daily starting 7 days before RFA and continuing for 30 days postoperatively, plus standard care * Control group: Standard care alone (RFA plus compression stockings)

All patients will undergo standardized RFA procedure under tumescent anesthesia. Assessments will be performed at baseline, and postoperative days 1, 7, 14, 30, and 90. Primary endpoint is pain score (VAS) at day 7. Secondary endpoints include VCSS, CIVIQ-20 quality of life score, ecchymosis score, analgesic use, and time to return to normal activities.

Вмешательства

Препарат calcium dobesilate
Calcium dobesilate 500 mg oral tablet, twice daily (morning and evening), starting 7 days before radiofrequency ablation and continuing for 30 days postoperatively. Total treatment duration is 37 days.

Первичные конечные точки

Postoperative Pain Score (VAS) [Срок оценки: Postoperative day 7]

Вторичные конечные точки (8)

Postoperative Pain Score at Day 14 and Day 30 [Срок оценки: Postoperative day 14 and day 30]
Venous Clinical Severity Score (VCSS) [Срок оценки: Baseline, day 30, and day 90]
Quality of Life (CIVIQ-20) [Срок оценки: Baseline, day 14, day 30, and day 90]
Ecchymosis Score [Срок оценки: Postoperative day 1, day 7, and day 14]
Time to Return to Normal Activities [Срок оценки: Up to 30 days postoperatively]
Postoperative Paresthesia Incidence [Срок оценки: Postoperative day 7, day 30, and day 90]
Endovenous Heat-Induced Thrombosis (EHIT) Incidence [Срок оценки: Postoperative day 7]
Great Saphenous Vein Occlusion Rate [Срок оценки: Postoperative day 30 and day 90]

Критерии участия

Критерии включения

Age 18-70 years
Symptomatic primary varicose veins (CEAP classification C2-C4)
Great saphenous vein insufficiency confirmed by duplex ultrasound (reflux >0.5 seconds)
Great saphenous vein diameter 5-12 mm
Scheduled for radiofrequency ablation
Able to provide written informed consent